【英文标准名称】:MedicalElectricalEquipment8212;ParticularRequirementsfortheBasicSafetyandEssentialPerformanceofPulseOximeterEquipmentforMedicalUse
【原文标准名称】:医用电气设备-医用脉动式血氧计的基本安全和性能的特殊要求
【标准号】:ASTMISO9919-2005
【标准状态】:现行
【国别】:美国
【发布日期】:2005
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:
【标准类型】:(ISO)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:ThisInternationalStandardspecifiedparticularrequirementforthebasicsafetyandessentialperformanceofpulseoximeterequipmentintendedforuseonhumans.Thisincludesanypartnecessaryfornormaluse,e.g.thepulseoximetermonitor,pulseoximeterprobe,probecableextender.Theserequirementsalsoapplytopulseoximeterequipment,includingpulseoximetermonitors,pulseoximeterprobesandprobecableextenders,thathasbeenreprocessed.Theintendeduseofpulseoximeterequipmentincludesbutisnotlimitedto,theestimationofarterialoxygenhaemoglobinsaturationandpulserateonpatientsinhealthcareinstitutionsaswellasonpatientsinhomecare.*ThisInternationalStandardisnotapplicabletopulseoximterequipmentintendedforuseinlaboratoryresearchapplicationsnortooximetersthatrequiresabloodsamplefromthepatient.ThisInternationalStandardisnotapplicabletoremoteorslave(secondary)devicesthatdisplaySpO2valuesthatarelocatedoutsideofthepatientenvironment.TherequirementsofthisInternationalStandardwhichreplaceormodifyrequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.
【中国标准分类号】:C39
【国际标准分类号】:11_040_10
【页数】:93P.;A4
【正文语种】:英语